Healing Abutment

GUDID 08800070204542

Izenimplant Co., Ltd.

Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID08800070204542
NIH Device Record Key6d2047c8-bff3-4bcc-8984-6ae354770270
Commercial Distribution StatusIn Commercial Distribution
Brand NameHealing Abutment
Version Model NumberHATR805
Company DUNS694625347
Company NameIzenimplant Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800070204542 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-16
Device Publish Date2022-05-06

On-Brand Devices [Healing Abutment]

08800070204542HATR805
08800070204535HATR804
08800070204528HATR803
08800070204511HATR709
08800070204504HATR707
08800070204498HATR705
08800070204481HATR704
08800070204474HATR703
08800070204467HATR609
08800070204450HATR607
08800070204443HATR605
08800070204436HATR604
08800070204429HATR603
08800070204412HATR509
08800070204405HATR507
08800070204399HATR505
08800070204382HATR504
08800070204375HATR503
08800070204368HATR459
08800070204351HATR457
08800070204344HATR455
08800070204337HATR454
08800070204320HATR453
08800070204313HATR409
08800070204306HATR407
08800070204290HATR405
08800070204283HATR404
08800070204276HATR403
08800070204269HATM459
08800070204252HATM457
08800070204245HATM455
08800070204238HATM454
08800070204221HATM453
08800070204214HATM409
08800070204207HATM407
08800070204191HATM405
08800070204184HATM404
08800070204177HATM403
08800070204160HASR905
08800070204153HASR904
08800070204146HASR903
08800070204139HASR805
08800070204122HASR804
08800070204115HASR803
08800070204108HASR659
08800070204092HASR657
08800070204085HASR656
08800070204078HASR655
08800070204061HASR654
08800070204054HASR653

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